Shanghai, China, February 2nd, 2023 -Shanghai Henlius Biotech, Inc. (2696.HK) announced a phase 1b/2 clinical trial of the company's HLX07, an anti-epidermal growth factor receptor (EGFR) humanised monoclonal antibody (mAb) injection, has been completed in patients with advanced solid tumours. The results of this study demonstrated the good safety and tolerability of HLX07.
This open-label, dose-escalation, phase 1b/2 study aimed to evaluate the safety and maximum tolerated dose (MTD) of HLX07 combined with different chemotherapy regimens in patients with advanced solid tumours. This study followed Bayesian optimal interval design (BOIN). Eligible patients were given different doses of intravenous HLX07 (400, 600, or 800 mg once weekly) combined with three fixed-dose chemotherapy regimens, respectively. The chemotherapy regimens were (1) gemcitabine and cisplatin; (2) paclitaxel and carboplatin; and (3) mFOLFOX6 regimen. The primary endpoints of this study were the incidence of dose limiting toxicities (DLT) and the MTD of HLX07 when combined with different chemotherapy regimens. Secondary endpoints included the incidence and types of adverse events and preliminary efficacy. The results showed that no DLT related to HLX07 occurred during the study, and the MTD of HLX07 was not reached when combined with different chemotherapy regimens. HLX07 was safe and well tolerated.
HLX07 is an innovative drug targeting EGFR independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07 to reduce the immunogenicity and maintain high affinity of the product. As of now, Henlius holds patents of HLX07 in several jurisdictions including China, the United States, the European Union, Australia, and Japan. Moreover, Henlius has received clinical trial approvals for HLX07 in China and the United States. As for used in the combination immunotherapies with HANSIZHUANG (serplulimab), the first patients were dosed in China in phase 2 clinical trials of HLX07 in combination with HANSIZHUANG (serplulimab) for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck (HNSCC) and EGFR high expression squamous non-small cell lung cancer (sqNSCLC). In addition, the investigational new drug (IND) application for the phase 2 clinical trial of HLX07 in combination with HANSIZHUANG (serplulimab) and HANBEITAI (bevacizumab biosimilar) for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA).
Henlius will always place a high value on clinical data and will continue to diversify innovation by strengthening internal innovation capabilities and external collaboration, extending new drug forms, and processing more clinical trials to generate more effective treatments.